Corneal Ulcer of Bilateral EyesNCT06540131
Studying the Effect of Ethanol Applied on the Corneal Surface During PRK Surgery.
An observational study of Corneal Ulcer of Bilateral Eyes, run by Minia University at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the effects of the duration of ethanol contact with the corneal surface. The main question it aims to answer is: Does this affect the behavior of corneal epithelial healing? Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Corneal Ulcer of Bilateral Eyes
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2024to 25 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients seeking refarctive surgery
Who may be able to join
- The included patients should meet the following criteria: age between 18 and 35 years, both genders, with normal corneal topography, clear cornea, and stable refractive error for at least 12 months before the surgery. Both eyes should have low to moderate myopia with spherical error of more than -4D spherical error, cylindrical error of more than -1.5D, and an estimated stromal ablation depth of less than 70 µm.
Who cannot join
- The patients were excluded from the study if they had one or more of the following findings: patients with mixed astigmatism in either eye, contact lens wearers, abnormal corneal topography, thin cornea less than 500 microns, corneal opacity, dry eye disease, history of herpetic keratitis, corneal epithelial pathology (dystrophies or scarring), atopy, collagen diseases, autoimmune disease, systemic diseases that interfere with healing (e.g. diabetes mellitus), eyelid diseases, ocular pathology, previous history of refractive or corneal surgery, and pregnant or lactating females. Also, patients who failed to attend the follow-up visits were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Ethyle Alcohol Contact Time on Corneal Epithelial Healing in Cases of Photorefractive Keratectomy
The goal of this observational study is to learn about the effects of the duration of ethanol contact with the corneal surface. The main question it aims to answer is: Does this affect the behavior of corneal epithelial healing?
Read the detailed description
The study was carried out on 70 patients who were candidates for laser corneal refractive surgery with alcohol-assisted PRK. The study comprised two groups. Group 1 included the right eye of the patients, and Group 2 included the left eye of the same patients. Group 1 was operated with PRK with alcohol 20% applied for 15 seconds, while group 2 underwent PRK with alcohol 20% applied for 30 seconds. Mitomycin C (MMC) 0.02% was applied for 30 seconds after the laser ablation in both groups.
Inclusions criteria:
The included patients should meet the following criteria: age between 18 and 35 years, both genders, with normal corneal topography, clear cornea, and stable refractive error for at least 12 months before the surgery. Both eyes should have low to moderate myopia with spherical error of more than -4D spherical error, cylindrical error of more than -1.5D, and an estimated stromal ablation depth of less than 70 µm.
Exclusion criteria:
The patients were excluded from the study if they had one or more of the following findings: patients with mixed astigmatism in either eye, contact lens wearers, abnormal corneal topography, thin cornea less than 500 microns, corneal opacity, dry eye disease, history of herpetic keratitis, corneal epithelial pathology (dystrophies or scarring), atopy, collagen diseases, autoimmune disease, systemic diseases that interfere with healing (e.g. diabetes mellitus), eyelid diseases, ocular pathology, previous history of refractive or corneal surgery, and pregnant or lactating females. Also, patients who failed to attend the follow-up visits were excluded.
Preoperative assessment The following preoperative measurements and examinations were performed. Uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA) using Snellen's charts. Manifest and cycloplegic refractions were measured with the autorefractor/keratometer. Intraocular pressure measurement was done using the I Care Tonometer. Clinical examination with the slit-lamp biomicroscopy, including dilated fundus examination of the posterior segment. Then patients were examined with Pentacam HR (Oculus Optikger- ate GmbH, Wetzlar, Germany) for corneal assessment and with I design for higher order aberration measurement.
Operative details:
Preoperatively, antibiotic (Moxifloxacin hydrochloride 0.5%) and anesthetic (benoxinate hydrochloride 0.4%) eye drops were instilled on the corneal surface. Povidone-iodine 5% solution was used for sterilization, and an eyelid closed loop speculum was used to keep the eyes wide open during the procedure.
Epithelial removal was done with a sponge soaked in a 20% ethanol solution applied on the central corneal surface for 15 seconds in the right eye (group 1) and for 30 seconds in the left eye (group 2) of the same patient. Then, the corneal surface was flushed with a balanced salt solution (BSS) to remove alcohol remnants. This was followed by epithelial delamination with a dry cellulose sponge to debride an 8 mm area. A blunt spatula was used to complete this step if epithelial removal was difficult with the sponge.
Subsequently, customized PRK was performed on the dry Bowman's layer surface by VISX star S4™ excimer laser [Abbott Medical Optics Inc. (AMO), Santa Ana, CA, USA]. The targeted postoperative refraction was emmetropia for all patients.
The patients were treated with topical instillation of antibiotic drops (gatifloxacin 0.5%) four times daily for one week, topical instillation of steroid drops (prednisolone 1%) four times daily for 2 weeks, then 3 times for 2 weeks, At the second month, prednisolone was substituted by fluorometholone (0.1%) drops for 2 weeks\& artificial tear drops (sodium hyaluronate 0.2%) five times daily for 3-months. An adjuvant therapy was added to the standard treatment regimen to augment the epithelial healing process: vitamin C 500 mg capsules twice per day \& vitamin A 50.000 I.U. capsules once per day, both for 2 weeks.
All patients were examined daily until complete epithelial healing, then after 1 week and 3 weeks. Contact lenses were removed for all patients after 7 days.
Pain assessment:
The patients recorded their pain using a validated numerical rating scale (NRS), where the patients subjectively rated their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst imaginable pain).16
- Conditions
- Corneal Ulcer of Bilateral Eyes
- Keywords
- PRK, ethanol, corneal ulcer
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group of 15 seconds ethanol | Group of eyes with ethanol applied on the corneal surface for 15 seconds | |
| group of 30 seconds ethanol | Group of eyes with ethanol applied on the corneal surface for 30 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
epithelial healing
assessment of the time at which corneal epithelium is completely healed after PRK surgery
Measured: The patients were folllowed daily upto 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start5 Mar 2024
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal Ulcer of Bilateral EyesStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Omar, Minia University
- Investigators
- Ismail Omar, MD, Principal investigator, Associate professor of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540131
- Sponsor's protocol ID
- 1093/03/2024
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared only on request from the principal investigator
Publications
Goodman GL, Trokel SL, Stark WJ, Munnerlyn CR, Green WR. Corneal healing following laser refractive keratectomy. Arch Ophthalmol. 1989 Dec;107(12):1799-803. doi: 10.1001/archopht.1989.01070020881031.
PubMed 2597070
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ethyle Alcohol Contact Time on Corneal Epithelial Healing in Cases of Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT06540131
- Acronym / sponsor ID
- 1093/03/2024
- Conditions
- Corneal Ulcer of Bilateral Eyes
- Keywords
- PRK, ethanol, corneal ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the effects of the duration of ethanol contact with the corneal surface. The main question it aims to answer is: Does this affect the behavior of corneal epithelial healing?
Detailed description
The study was carried out on 70 patients who were candidates for laser corneal refractive surgery with alcohol-assisted PRK. The study comprised two groups. Group 1 included the right eye of the patients, and Group 2 included the left eye of the same patients. Group 1 was operated with PRK with alcohol 20% applied for 15 seconds, while group 2 underwent PRK with alcohol 20% applied for 30 seconds. Mitomycin C (MMC) 0.02% was applied for 30 seconds after the laser ablation in both groups.
Inclusions criteria:
The included patients should meet the following criteria: age between 18 and 35 years, both genders, with normal corneal topography, clear cornea, and stable refractive error for at least 12 months before the surgery. Both eyes should have low to moderate myopia with spherical error of more than -4D spherical error, cylindrical error of more than -1.5D, and an estimated stromal ablation depth of less than 70 µm.
Exclusion criteria:
The patients were excluded from the study if they had one or more of the following findings: patients with mixed astigmatism in either eye, contact lens wearers, abnormal corneal topography, thin cornea less than 500 microns, corneal opacity, dry eye disease, history of herpetic keratitis, corneal epithelial pathology (dystrophies or scarring), atopy, collagen diseases, autoimmune disease, systemic diseases that interfere with healing (e.g. diabetes mellitus), eyelid diseases, ocular pathology, previous history of refractive or corneal surgery, and pregnant or lactating females. Also, patients who failed to attend the follow-up visits were excluded.
Preoperative assessment The following preoperative measurements and examinations were performed. Uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA) using Snellen's charts. Manifest and cycloplegic refractions were measured with the autorefractor/keratometer. Intraocular pressure measurement was done using the I Care Tonometer. Clinical examination with the slit-lamp biomicroscopy, including dilated fundus examination of the posterior segment. Then patients were examined with Pentacam HR (Oculus Optikger- ate GmbH, Wetzlar, Germany) for corneal assessment and with I design for higher order aberration measurement.
Operative details:
Preoperatively, antibiotic (Moxifloxacin hydrochloride 0.5%) and anesthetic (benoxinate hydrochloride 0.4%) eye drops were instilled on the corneal surface. Povidone-iodine 5% solution was used for sterilization, and an eyelid closed loop speculum was used to keep the eyes wide open during the procedure.
Epithelial removal was done with a sponge soaked in a 20% ethanol solution applied on the central corneal surface for 15 seconds in the right eye (group 1) and for 30 seconds in the left eye (group 2) of the same patient. Then, the corneal surface was flushed with a balanced salt solution (BSS) to remove alcohol remnants. This was followed by epithelial delamination with a dry cellulose sponge to debride an 8 mm area. A blunt spatula was used to complete this step if epithelial removal was difficult with the sponge.
Subsequently, customized PRK was performed on the dry Bowman's layer surface by VISX star S4™ excimer laser [Abbott Medical Optics Inc. (AMO), Santa Ana, CA, USA]. The targeted postoperative refraction was emmetropia for all patients.
The patients were treated with topical instillation of antibiotic drops (gatifloxacin 0.5%) four times daily for one week, topical instillation of steroid drops (prednisolone 1%) four times daily for 2 weeks, then 3 times for 2 weeks, At the second month, prednisolone was substituted by fluorometholone (0.1%) drops for 2 weeks\& artificial tear drops (sodium hyaluronate 0.2%) five times daily for 3-months. An adjuvant therapy was added to the standard treatment regimen to augment the epithelial healing process: vitamin C 500 mg capsules twice per day \& vitamin A 50.000 I.U. capsules once per day, both for 2 weeks.
All patients were examined daily until complete epithelial healing, then after 1 week and 3 weeks. Contact lenses were removed for all patients after 7 days.
Pain assessment:
The patients recorded their pain using a validated numerical rating scale (NRS), where the patients subjectively rated their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst imaginable pain).16
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group of 15 seconds ethanol | – | –Group of eyes with ethanol applied on the corneal surface for 15 seconds |
| group of 30 seconds ethanol | – | –Group of eyes with ethanol applied on the corneal surface for 30 seconds |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients seeking refarctive surgery
Key inclusion criteria (1 listed)
- The included patients should meet the following criteria: age between 18 and 35 years, both genders, with normal corneal topography, clear cornea, and stable refractive error for at least 12 months before the surgery. Both eyes should have low to moderate myopia with spherical error of more than -4D spherical error, cylindrical error of more than -1.5D, and an estimated stromal ablation depth of less than 70 µm.
Key exclusion criteria (1 listed)
- The patients were excluded from the study if they had one or more of the following findings: patients with mixed astigmatism in either eye, contact lens wearers, abnormal corneal topography, thin cornea less than 500 microns, corneal opacity, dry eye disease, history of herpetic keratitis, corneal epithelial pathology (dystrophies or scarring), atopy, collagen diseases, autoimmune disease, systemic diseases that interfere with healing (e.g. diabetes mellitus), eyelid diseases, ocular pathology, previous history of refractive or corneal surgery, and pregnant or lactating females. Also, patients who failed to attend the follow-up visits were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
epithelial healing
Time frame: The patients were folllowed daily upto 2 weeks
assessment of the time at which corneal epithelium is completely healed after PRK surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Results publication: PubMed 2597070Goodman GL, Trokel SL, Stark WJ, Munnerlyn CR, Green WR. Corneal healing following laser refractive keratectomy. Arch Ophthalmol. 1989 Dec;107(12):1799-803. doi: 10.1001/archopht.1989.01070020881031.
- Individual participant dataSharing planned: No. It will be shared only on request from the principal investigator
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Omar, MD principal investigator
Associate professor of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ulcer of Bilateral Eyes, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epithelial healing (time frame: The patients were folllowed daily upto 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.